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Tacrolimus is highly effective in both dual and triple therapy regimens following renal transplantation. Spanish and Italian Tacrolimus Study Group.
- Source :
-
Transplant international : official journal of the European Society for Organ Transplantation [Transpl Int] 2000; Vol. 13 Suppl 1, pp. S336-40. - Publication Year :
- 2000
-
Abstract
- This open, multicenter, randomized, parallel-group study evaluated the efficacy and safety of tacrolimus-based dual and triple therapy regimens. For this 3-month study (with 12-month follow up), 491 adult renal transplant patients were randomized and received either dual therapy (tacrolimus/corticosteroids; 246 patients) or triple therapy (tacrolimus/corticosteroids/azathioprine; 245 patients). Patient survival rates at months 3 and 12 were 99.2 (dual) vs 99.6% (triple) and 97.8 vs 98.7%, respectively. Graft survival rates at months 3 and 12 were 94.1 (dual) vs 95.4% (triple) and 92.8 vs 93.3%, respectively. After 3 months, the incidences of treated acute rejection were 28.8 (dual) and 29.7% (triple); and 7.6 (dual) and 5.4% (triple) for corticosteroid-resistant acute rejections. Between months 4 and 12, three new first rejections were reported, (dual: 2, triple: 1). For leukopenia (1.3 vs 11.7%; P < 0.001) and anemia (14.8 vs 23.0%, P = 0.026), significantly higher incidences were reported in the triple therapy group. The incidence of de novo insulin-dependent diabetes was 5.6 (dual) and 4.0% (triple) at month 3. In terms of efficacy, no difference between the treatment groups was observed.
- Subjects :
- Acute Disease
Adult
Aged
Drug Therapy, Combination
Female
Graft Rejection drug therapy
Graft Rejection prevention & control
Graft Survival
Humans
Immunosuppressive Agents blood
Immunosuppressive Agents pharmacokinetics
Incidence
Italy
Kidney Transplantation mortality
Kidney Transplantation physiology
Male
Middle Aged
Patient Selection
Reoperation
Spain
Survival Rate
Tacrolimus blood
Tacrolimus pharmacokinetics
Time Factors
Graft Rejection epidemiology
Immunosuppressive Agents therapeutic use
Kidney Transplantation immunology
Tacrolimus therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0934-0874
- Volume :
- 13 Suppl 1
- Database :
- MEDLINE
- Journal :
- Transplant international : official journal of the European Society for Organ Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 11112027
- Full Text :
- https://doi.org/10.1007/s001470050356